South Centre Paper Sees IP In Free Trade Agreements Interfering With UN SDGs
By Kim Treanor
A new paper from the intergovernmental South Centre argues that intellectual property provisions in recent free trade agreements would impair countries trying to fulfil the United Nations Sustainable Development Goals.
The South Centre, the Geneva-based developing country group, has released the research paper entitled, “Mitigating the Regulatory Constraints Imposed by Intellectual Property Rules under Free Trade Agreements,” by Special Advisor on Trade and Intellectual Property Carlos Correa.
In the paper, Correa argues that free trade agreements, using examples of primarily US-led FTAs, contain intellectual property provisions that constrain countries’ abilities to fulfill Goal 10 of the UN Sustainable Development Goals, reducing inequality within and among countries.
Correa argues that many FTAs contain provisions that require countries to implement regulations beyond those required under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which all WTO members are required to adopt.
TRIPS requirements include the standardisation of patent terms to a uniform 20 years, and demand that domestic institutions adopt measures to register and enforce patents. While countries are bound to these rules, the TRIPS agreement allows each country to use “flexibilities” within the agreement, notably the ability to issue compulsory licences or parallel imports when necessary to protect public health.
Correa argues that FTAs often contain additional requirements, called “TRIPS-plus” and “TRIPS-extra” provisions. Demands in these categories, per Correa, include the obligation of extending patent protection to known medications when a new use or method is found, extending patent terms to account for regulatory delays in approval, or requiring “data exclusivity” for biologic drugs. This exclusivity is essentially the practice of preventing regulators from reviewing clinical trial data of a brand name drug in order to compare the safety and efficacy of any biosimilar or generic competitor, and preventing generic manufacturers from using this data to make competing medicines.
Correa criticises the impact of the TRIPS agreement, stating that the implementation of the agreement hurt access to medicines in low and middle income countries, that the agreement did not assist in generating the research and development funding for the diseases which affect developing countries, and that there is no evidence that strict IP protection has led to increased foreign investment.
It is not only the IP requirements within FTAs, the paper argues, that place onerous requirements on countries. Correa points to the certification process used by the Office of the US Trade Representative to argue that after an FTA is signed and prior to its entry into force, the trade representative can review the other party’s laws and apply pressure to limit any flexibilities retained in their domestic law. Correa also argues that further pressures are placed on trading partners by the US by placing them on the USTR “watch list” under the annual Special 301 report, which assesses the United States opinion on global protection of US IP.
These extra pressures seem especially poignant as Correa moves to discuss the flexibilities within many FTAs that can be utilised by national governments. Correa argues that depending on the requirements of the FTA, authorities in member states can limit protections on test data and restrain patent linkage, a system that links a drug’s patent status to its marketing approval. Flexibilities for test data exclusivity may include protecting only undisclosed test data, waiving data exclusivity if a compulsory licence is issued or for public health reasons, and ensuring that data exclusivity only applies to the commercialisation of a product, and not distribution for humanitarian reasons.
In order to mitigate ill effects on public health from patent linkage, Correa advocates for making the patentee liable for damages when linkage claims are “unduly used to exclude generic products from the market,” and recommends that linkage provisions only apply to patents of active ingredients in a drug.
Correa’s argument is that TRIPS-plus and TRIPS-extra provisions such as those discussed above will exacerbate inequalities between countries and place a strain on access to medicines within low and middle income countries. To this end, he recommends that countries must use the flexibilities within TRIPS and within any free trade agreement which they sign to the fullest extent, in order to mitigate the negative impacts of requirements in these agreements.
This article was published by the Intellectual Property Watch (IP-Watch) on 27 February 2017.
